510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,502

176,299 records, page 3344 of 3526

510(k) clearances, page 3344 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801359	Pruitt Vascular Shunt	Ideas for Medicine, Inc.	DWF	Class II	1980-07-28
K801351	Epilator, Model Cp-16	R. A. Fischer Co. Corp.	KCW	Class I	1980-07-28
K801336	Model 900K Photocoagulator	Coherent Medical Division	HQF	Class II	1980-07-28
K801303	Model 90 Pressure/conductivity/temp Test	Western Laboratories Corp.	KDI	Class II	1980-07-28
K801285	Ysi Models 23C & 23Cm Hdl & Total Choles	Yellow Springs Instrument Co., Inc.	CHH	Class I	1980-07-28
K801273	Magill Catheter Intro. Forceps	J. Sklar Mfg. Co., Inc.	KOA	Class I	1980-07-28
K801247	Ccd Endoscope and Attachments	Welch Allyn Inc	GCP	Class II	1980-07-28
K801178	Cobe Hf80, Cat. #18-580	Cobe Laboratories, Inc.	FJI	Class II	1980-07-28
K801169	Ohio Free Flow Vacuum Regulator	Ohio Medical Products	KDP	Class II	1980-07-28
K801113	Dilator, Vessel, for Perc. Catheter.	Alva Medical, Inc.	DRE	Class II	1980-07-28
K801031	Blade Septostomy Catheter	Cook, Inc.	DXF	Class II	1980-07-28
K801024	Odor Masking Agent in Boundary Obstetri.	The Buckeye Cellulose Corp.	HHL	Class II	1980-07-28
K801021	Urinebag	Unovex of Denmark	KNX	Class II	1980-07-28
K800918	Modified Feeding Jejunostomy Tube	Mitchell V. Kaminski, Jr., M.D.	KNT	Class II	1980-07-28
K800749	Ipocon 7	Ipos Luneburg	ITG	Class I	1980-07-28
K801620	Aspirator	Marquest Medical Products, Inc.	CBT	Class I	1980-07-21
K801592	Fiber Optic Hose	Lares Manufacturing Co., Inc.	EAY	Class I	1980-07-21
K801591	Fiber Optic Illuminator	Lares Manufacturing Co., Inc.	EAY	Class I	1980-07-21
K801587	Ash Blueprint Alginate Impression Mater.	Dentsply Intl.	ELW	Class II	1980-07-21
K801567	Cybrex Theophylline	Abbott Medical			1980-07-21
K801566	Cybrex Phenobarbital	Abbott Medical			1980-07-21
K801565	Cybrex Phenytoin	Abbott Medical			1980-07-21
K801557	Rolls Rollite Wheelchair	Invacare GmbH	IOR	Class I	1980-07-21
K801551	Argyle Saf-T-Mark Suction Catheter	Sherwood Medical Co.	BSY	Class I	1980-07-21
K801548	Perf-Lock Impression Tray	Dentsply Intl.	EHY	Class I	1980-07-21
K801531	Arm Sling	The Owenby Co.	ILI	Class I	1980-07-21
K801526	Surveyor I, Respiratory Computer System	The Devilbiss Co.	BZC	Class II	1980-07-21
K801525	Zest Endodontic Stabilizer	Zest Anchors LLC	ELS	Class II	1980-07-21
K801524	Zest Plant	Zest Anchors LLC	DZE	Class II	1980-07-21
K801496	Pulmonary Lab Automation System	Medical Graphics Corp.	BZM	Class II	1980-07-21
K801495	Cardio-Pulmonary Exercise Stress System	Medical Graphics Corp.	BZM	Class II	1980-07-21
K801484	Root Canal Filling Applicator Needles	National Patent Development Corp.	EIC	Class I	1980-07-21
K801483	Mark IV Syringe	National Patent Development Corp.	EIC	Class I	1980-07-21
K801482	Hydron Root Canal Filling Material	National Patent Development Corp.	KIF	Class II	1980-07-21
K801463	Oj-1 Endodonic Root Canal File Holder	Almore Intl., Inc.	EKQ	Class I	1980-07-21
K801449	Blood Gas Control Prod. No. Bg-1, Bg-2	Health Diagnostics Corp.	JJS	Class I	1980-07-21
K801448	Oticon Model E17p Earette Hearing Aid	Oticon, Inc.	ESD	Class I	1980-07-21
K801440	Sorb 10 Dialysate Infusate C1 Infusate	bioMerieux, Inc.	FKT	Class II	1980-07-21
K801439	Model 5100 Electrochemical Detector	Environmental Sciences Assoc., Inc.	LEQ	Class I	1980-07-21
K801424	Estriol Ria Kit for Use with Gammaflo	Squibb & Sons, Inc.	CGI	Class I	1980-07-21
K801418	Keeler Amoils Acull Cryo Ophthalmic Unit	Keeler Optical Products, Ltd.	HPS	Class II	1980-07-21
K801411	May Illuminated/infusion Pic	Cooper Medical Devices Corp.	HMX	Class I	1980-07-21
K801410	Hemohlobin A2 Control-Lyophilized	Isolab, Inc.	JPD	Class II	1980-07-21
K801385	K1 Potassium Acetate Additive	bioMerieux, Inc.	FKT	Class II	1980-07-21
K801370	Gf-120-L Dialyzer	Gambro, Inc.	FJI	Class II	1980-07-21
K801368	A2 Image Processing System	Medtronic, Inc.	IYX	Class I	1980-07-21
K801362	Albumin Nephelometric Assay	J.T. Baker Chemical Co.	JQX	Class I	1980-07-21
K801358	New Freedom Anyday Pantiliners	Kimberly-Clark Corporation	HHL	Class II	1980-07-21
K801344	Extracorporeals' Alternate Membrane	Extracorporeal Medical Specialities, Inc.	FJI	Class II	1980-07-21
K801341	Tan Year Round Sun Bed	Tan-Year Round, Inc.	LEJ	Class II	1980-07-21